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MKH is a Chemist, Validation and Compliance Specialist, cGMP Regulatory Compliance Consultant, Quality, Production, and Engineering Management Consultant with world-class expertise in regulatory compliance, training, validation, and quality, production, and new product development management
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This KKAI Consultant has held a number of executive positions for over 25 years in the pharmaceutical industry in Manufacturing, Quality, and Product Development. During that time he has led or participated in project teams that commercialized over a dozen product formulations.
This consultant has led the development of cross-functional and high performance teams in many organizations. He transformed a compartmentalized management structure at a pharmaceutical plant into a team driven system with fewer layers of management. The business impact of this transformation was that projects that had invariably been over budget and late came in on-budget and on schedule.
The first business process that this associate transformed was new product commercialization. The traditional method of managing projects is a very linear process. R&D comes up with a product, then tosses the package over the wall to the Process Development department. The process development department heaves its package over the wall to Engineering, who then launches its package at Manufacturing. Manufacturing turns the product over to Marketing, who must now figure out how to get customers to buy a product which may have only coincidental resemblance to the marketplace need that they had identified to R&D in the first place.
The trick in any team building project is to unite a group of people with different skills, experience, and personalities around a common goal and make the whole greater than the sum of the parts. The leader must insure that the conflict that arises when a diverse, motivated team works closely together is controlled and creative rather than destructive.
There were many changes in organizational structure and management practices that were implemented in order to make this transformation successful. Here are a few of the major ones.
The annual Goals and Objectives of the technical personnel, R&D, Engineering, Manufacturing and Quality Assurance, were set such that they were responsible for the TOTAL success of their projects, not just their own portion of the projects. Managers in each of these departments had input into the performance reviews of employees in the other departments.
Everyone had to learn how to hold more effective meetings. Cross-functional teams are easily strangled by interminable, boring meetings. Some of the learning highlights: When is a meeting necessary? What is the difference between a working meeting and a communication meeting? What is the importance of getting everyone’s input? How do you cut off the longwinded grandstanders?
In this particular case the associate had an advantage in that the plant had a steady capital budget for the next five years. This allowed for the reassignment of a core group of engineers to be co-located with the production personnel. The production and engineering staff were intermingled. They used the same coffee pot, the same lunchrooms, the same bathrooms. They sat in the same meetings with the Marketing and R&D personnel when new products were being developed.
The consultant has led multinational project teams to develop new pharmaceutical products. He insured that all members of the teams contributed despite the fact that they came from multiple countries and multiple companies. As plant manager of an API plant he led the investment in over $10M of capital per year, all of which was on time and on budget. Among these projects was an advanced technology distillation column, the most advanced production distillation column in the world at the time. In addition he installed a new Distributed Control System, which allowed the identification of Key Process Parameters. Using SPC he established allowable ranges for the Key Process Parameters. By keeping the parameters within those ranges product quality was improved, end of pipe testing was reduced, downtime was minimized, and equipment reliability was improved. Overall savings were $1.8M/yr. He used Design of Experiment techniques to reduce product overages and save $300k/y. He expanded plant capacity by 30% while simultaneously reducing emissions. Used SPC to reduce variability in Spray Drying Plant and saved $200k/y.
Read other articles by this KKAI Associate:
Transformation to a High Quality Culture
| Chemist, Validation and Compliance Specialist, cGMP Regulatory Compliance Consultant, Quality, Production, and Engineering Management Consultant, regulatory compliance, training, validation, and quality, production, and new product development management | |
| Resume of MID | lean manufacturing engineer, mechanical engineer, manufacturing engineer, program manager, consultant, specialist, forensic analysis, investigation, product liability, expert witness testimony, engineering consulting services |
| Resume of OJF | electrical engineer, manufacturing engineer, electronics design engineer, gd&t consultant, engineering failure analysis, accident investigation, accident reconstruction, specialist, forensic investigation, product liability, expert witness testimony, engineering consulting services |
| Resume of CZU | organizational development specialist, human resource consultant, leadership, management, educator, specialist, forensic analysis investigation expert witness testimony, consulting services |
| Resume of KMZ | quality process engineer, quality management specialist, lean consultant, spc and fmea specialist, problem solving consultant, engineering failure analysis, accident investigation, accident reconstruction, specialist, forensic analysis investigation expert witness testimony, engineering consulting services |
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